Key Abstracts:
Abstract title Authors Presentation date/time
Efficacy and safety outcomes up to ~4 years of treatment with filgotinib 200mg among patients with Ulcerative Colitis: Results from the SELECTION LTE study Brian Feagan, Katsuyoshi Matsuoka, Gerhard Rogler, Margaux Faes, Alessandra Oortwijn, Angela de Haas, Christine Rudolph and Laurent Peyrin-Biroulet Oral presentation
Presentation number: OP35
Presentation date, time & location: Saturday 4 March 2023, 09:50-10:00, Plenary Hall
Session name: Sequencing in IBD - Scientific Session 10: Evolving goals
Prolonged benefit of filgotinib in patients with Ulcerative Colitis in SELECTION David Laharie, Andreas Sturm, Taku Kobayashi, Takayuki Matsumoto, Alessandra Oortwijn, Corinne Jamoul, Margaux Faes, Angela de Haas and Séverine Vermeire Poster presentation
Presentation number: P690
Presentation date, time & location: Friday 3 March 2023, 12:30-13:30, Poster Exhibition, Hall B5&6
Factors associated with partial Mayo Clinic Score over time in patients with Ulcerative Colitis treated with filgotinib in the phase 2b/3 SELECTION trial Laurent Peyrin-Biroulet, Edouard Louis, Tadakazu Hisamatsu, Corinne Jamoul, Eva Santermans, Kristina Harris, Angela de Haas, Alessandra Oortwijn and Brian Feagan Poster presentation
Presentation number: P736
Presentation date, time & location: Friday 3 March 2023, 12:30-13:30, Poster Exhibition, Hall B5&6
Effect of filgotinib on anaemia in patients with Ulcerative Colitis in SELECTION Roberta Loveikyte, Angela de Haas, Alessandra Oortwijn, Bart Eskens, Corinne Jamoul, Karine Muller and Andrea E. van der Meulen-de Jong Poster presentation
Presentation number: P393
Presentation date, time & location: Friday 3 March 2023, 12:30-13:30, Poster Exhibition, Hall B5&6
Thromboembolic and major adverse cardiovascular events among patients in the filgotinib clinical trial programme C Janneke van der Woude, Stefan Schreiber, Laurent Peyrin-Biroulet, Zoltán Szekanecz, Ernest HS Choy, Pieter-Jan Stiers, Paul Van Hoek, Katrien Van Beneden, Angela de Haas, Christine Rudolph and Hugo ten Cate Poster presentation
Presentation number: P520
Presentation date, time & location: Friday 3 March 2023, 12:30-13:30, Poster Exhibition, Hall B5&6
Investigating the symptom burden among European patients with moderate-to-severe Crohn’s disease using a real-world survey Johan Burisch, Ailsa Hart, Andreas Sturm, Hannah Knight, Christine Rudolph, Rachael Meadows, Alessandra Oortwijn, Sarah Weatherby, Roger Rolph, Fatima Dawod and Alessandro Armuzzi Poster presentation
Presentation number: P624
Presentation date, time & location: Friday 3 March 2023, 12:30-13:30, Poster Exhibition, Hall B5&6
About ulcerative colitis
UC is a debilitating inflammatory bowel disease (IBD) that occurs as a result of an abnormal immune system response. Across Europe an estimated 2.5 - 3 million people2 are affected by IBD, which includes UC and Crohn’s disease (CD). UC is a chronic inflammatory condition characterized by periods of flare ups followed by remission. In addition to the physical impact from flare ups, there is also a psychological impact associated with UC. It causes significant impairments on quality of life and a poor prognosis is often seen in patients with symptoms of moderate to severe UC at diagnosis.
About the SELECTION clinical program
The SELECTION program comprised of SELECTION and the associated long-term extension study (SELECTIONLTE).
The SELECTION Phase 3 study was a multi-center, randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of the preferential JAK1 inhibitor filgotinib in adult patients with moderate to severe active UC. The SELECTION study (NCT02914522) comprised of two induction trials and a maintenance trial. Induction Study A enrolled biologic-naïve patients and Induction Study B enrolled biologic-experienced patients. A majority of the patients included in the SELECTION study (n=1348) had a pMCS of 9 or higher at baseline, and 43% of biologic-experienced patients (n=297/689) had an insufficient response to a TNF antagonist and vedolizumab as well.3
The primary objectives of the SELECTION clinical program were to evaluate the efficacy of filgotinib compared with a placebo in establishing clinical remission as determined by the Mayo endoscopic sub-score, rectal bleeding sub-score, and decrease in stool frequency from baseline. Patients who completed the induction and maintenance studies, patients who were not responders at Week 10, and patients with disease worsening during the maintenance study were enrolled in the ongoing SELECTIONLTE study (NCT02914535) to evaluate the long-term safety and efficacy of filgotinib in patients suffering from UC. An interim report of SELECTIONLTE assessed the safety and efficacy of open-label filgotinib through to Week 144 in completers and through to Week 192 in non-responders, respectively.